Getinge ISOTEST Isolators
Getinge ISOTEST Isolators
Efficient and reliable sterility testing processes
Getinge ISOTEST is an isolator designed for sterility testing of sterile drugs, components, and devices. Continuous workflow, easy access, and fast bio-decontamination help increase productivity.
Sterility testing is the last mandatory control performed on sterile drugs before their release for patients. It must be performed inside a controlled sterile environment to avoid the risk of false positive results. The Getinge Isotest isolator is a completely closed system providing a controlled environment and optimal workflows for reliable sterility testing.
Compared to a cleanroom, isolators provide a smaller and simpler environment to be controlled. Sources of contamination can be detected immediately for greater control over process parameters and easier traceability.
The Getinge Isotest system design is optimized for sterility testing procedures. Two operators can have good simultaneous access to the chamber. This allows them to work simultaneously with the same or different sterility testing methods inside the isolator. The system can be used with any combination of closed or open membrane filtration, direct inoculation methods, and rapid microbiology methods (RMM).
Minimize downtime for improved throughput
The Getinge ISOTEST isolator facilitates a continuous testing process instead of a batch process, eliminating unproductive time between batches. Short bio-decontamination cycles and the capacity for dual operations combine for a throughput rate of up to 40 tests per 8-hour shift.*
* Based on an average test size on 20 ml containers / vials
The Getinge ISOTEST isolator offers the possibility to bio-decontaminate the total volume of the unit; the hatch can be included, or bio-decontaminated separately. Bio-decontamination of the load within the hatch occurs quickly for high productivity — often within 30-45 minutes. The integrated bio-decontamination unit uses hydrogen peroxide (H2O2) vapor (HPV) as sterilant. The generator is controlled by the same PLC as the unit, providing reliable operations.
Validated process control and traceability
Both the isolator and integral bio-decontamination unit are controlled by a single Siemens PLC control system. The control system monitors and records process-critical parameters that can be sent to a printer, remote PC (option); or stored in the customer network through SCADA integration (option).
A color touchscreen control panel is intuitive and easy to operate. Through the HMI, authorized users can set process parameters that operators can easily monitor during the process.
DPTE® Transfer Solutions
Safe and efficient waste handling
A dual-waste DPTE-BetaBag® allows for safe removal of liquid and solid waste from the isolator. The DPTE® system provides egress from inside the isolator chamber while maintaining isolator integrity; there is no risk of sample or environmental contamination
Reliable and efficient sterility testing
Getinge’s sterility testing isolators and patented DPTE® sterile transfer systems provide a safe and sterile self-contained environment for the most critical steps of the testing process.
Getinge Isoflex-R Isolators
The Getinge Isoflex-R Isolator protects the product against contamination during aseptic operations such as sterility testing. The isolator maintains an enclosed and sterile environment throughout transfer, manipulation, and bio-decontamination.
Getinge Isoflex-S Isolators
Getinge Isoflex-S isolators combine the robustness of a 316L stainless steel working base with the comfort of working with glove sleeves on a flexible wall.
Glove Leak Testers (GLT)
Ensure a safe production and process control with the paperless Glove Leak Tester that enables seamless in-situ glove testing.
DPTE®-XS Alpha Port
The core of the DPTE® transfer system is the Alpha port with its secure interlock enabling totally safe connections and disconnections. The DPTE® system enables material to be moved from one sterile zone to another through a non-sterile zone, with leak-tight, risk-free reconnection.
DPTE® Beta Containers
Available in polyethylene or stainless steel, the reusable DPTE® Beta Containers are designed for efficient loading and unloading of components and equipment into a sterile zone. The optional racks stabilize items inside the canisters while they are transferred and sterilized.
A maintenance-free Single-Use transfer solution for an efficient, flexible and scalable manufacturing process. The prefilled bag with components can be sterilized on-site or can be delivered ready-to-use by our different partners.